The WHITE Four randomized control trial, comparing X-Bolt Orthopaedics’ expanding bolt to a sliding hip screw (SHS, the current standard of care), has surpassed enrollment of 1,000 patients. The study reportedly represents the largest ever trial comparing extracapsular hip fracture fixation devices.
The multicenter randomized WHITE Four control trial, independently run by Oxford University’s Clinical Trials and Research Unit, follows Warwick Hip Trauma Evaluation One—a 100-patient trial that also compared X-Bolt to the SHS. WHITE One demonstrated a 0% re-operation rate with the X-Bolt device, as opposed to 6% for the SHS.
X-Bolt Orthopaedics founder Dr. Brian Thornes said, “Strong fixation will reduce reoperation rates that are typically around 5-6% with lag screw fixation. Reoperations are not well tolerated by this frail elderly cohort of patients and thus each reoperation episode on average adds $50,000 to the overall cost of care. The X-Bolt is set to reduce the reoperation rate to below 1%. We are delighted with the recruitment and progress of this large pragmatic trial that also includes higher risk patients with dementia, to prove statistical superiority and ultimately revolutionize the hip fracture fixation market.”
Source: X-Bolt Orthopaedics
The WHITE Four randomized control trial, comparing X-Bolt Orthopaedics' expanding bolt to a sliding hip screw (SHS, the current standard of care), has surpassed enrollment of 1,000 patients. The study reportedly represents the largest ever trial comparing extracapsular hip fracture fixation devices.
The multicenter randomized WHITE Four...
The WHITE Four randomized control trial, comparing X-Bolt Orthopaedics’ expanding bolt to a sliding hip screw (SHS, the current standard of care), has surpassed enrollment of 1,000 patients. The study reportedly represents the largest ever trial comparing extracapsular hip fracture fixation devices.
The multicenter randomized WHITE Four control trial, independently run by Oxford University’s Clinical Trials and Research Unit, follows Warwick Hip Trauma Evaluation One—a 100-patient trial that also compared X-Bolt to the SHS. WHITE One demonstrated a 0% re-operation rate with the X-Bolt device, as opposed to 6% for the SHS.
X-Bolt Orthopaedics founder Dr. Brian Thornes said, “Strong fixation will reduce reoperation rates that are typically around 5-6% with lag screw fixation. Reoperations are not well tolerated by this frail elderly cohort of patients and thus each reoperation episode on average adds $50,000 to the overall cost of care. The X-Bolt is set to reduce the reoperation rate to below 1%. We are delighted with the recruitment and progress of this large pragmatic trial that also includes higher risk patients with dementia, to prove statistical superiority and ultimately revolutionize the hip fracture fixation market.”
Source: X-Bolt Orthopaedics
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